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NCT02486380 Clinical Trial

Toffee Full Face and Toffee Nasal Mask Evaluation in Obesity Hypoventilation Syndrome (NZ)

Obesity Hypoventilation Syndrome Clinical Trial

Official title:
Toffee Full Face and Toffee Nasal Mask Evaluation in Obesity Hypoventilation Syndrome (NZ)

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02486380
Other study ID # CIA-162
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date July 2015
Est. completion date March 2017

Study information
Verified date June 2022
Source Fisher and Paykel Healthcare
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This investigation is to evaluate the performance, comfort and ease of use of the Toffee full face and toffee nasal mask masks amongst Obesity Hypoventilation Syndrome (OHS) patients in an overnight study.

Description:

Up to 20 OHS patients who currently use a full face mask or a nasal mask will be recruited. They will be issued a F&P Toffee Full face (if they are existing full face users) or F&P Toffee Nasal (if they are existing nasal users) for an overnight polysomnography.

Recruitment information / eligibility
Status Terminated
Enrollment 4
Est. completion date March 2017
Est. primary completion date March 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Aged 18+ - Diagnosed with OHS by a practicing physician - Existing full face mask user or a nasal mask user - Prescribed PAP therapy (Bi-Level or CPAP) Exclusion Criteria: - Inability to give informed consent - Pregnant or think they may be pregnant - Anatomical or physiological conditions making PAP therapy inappropriate - Patients requiring supplemental oxygen with their PAP device - Patients who are in a coma or decreased level of consciousness - Existing Toffee full face and Toffee nasal mask users - No arterial PCO2 value from their medical records

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Toffee full face mask/toffee nasal mask
Toffee full face mask/toffee nasal mask

Locations
Country Name City State
New Zealand Fisher & Paykel Healthcare Auckland

Sponsors (1)
Lead Sponsor Collaborator
Fisher and Paykel Healthcare

Country where clinical trial is conducted

New Zealand, 

Outcome
Type Measure Description Time frame Safety issue
Primary Objective Leak data Obtained from the participant's device and polysomnography (PSG) 1 night
Secondary Subjective measurement of Leak Questionnaire 1 night
Secondary Comfort Questionnaire 1 night
Secondary Ease of use Questionnaire 1 night
Secondary Sleep efficiency Obtained through the PSG 1 night
Secondary Wake after Sleep Onset (WASO) Obtained through the PSG 1 night
Secondary Arousal Index (AI) Obtained through the PSG 1 night
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